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U.S. Department of Health and Human Services

Product Classification
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Device appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeLXT
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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